FDA Approves Anakinra (Kineret™) for Treatment in Rheumatoid Arthritis
On November 16, the U.S. Food and Drug Administration (FDA) approved KineretTM (anakinra) for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in adult patients who have failed one or more disease modifying antirheumatic drugs (DMARDs). Kineret is the first selective blocker of interleukin-1 (IL-1). Kineret can be used alone or in combination with other DMARDs, but should not be used with the tumor necrosis factor blocking agents, etanercept and infliximab.
In clinical trials, most patients experienced a decrease in inflammation and pain by week 13 of treatment. 38% of patients treated with Kineret met ACR20 criteria for improvement as compared with 22% of patients receiving placebo. The most common side effect was an injection site reaction. The risk of serious infections was 2% in Kineret patients compared to less than 1% in placebo patients.
Kineret cannot be used in combination with TNF blocking agents because, in a small study, data has shown a higher incidence of serious infection than Kineret alone, 7%, and the occurence of neutropenia, 3%.
Kineret works by selectively blocking interleukin-1 (IL-1), which is thought to promote inflammation and pain in RA.